To survive in the increasingly competitive pharmaceutical industry, many players are boosting their in-licensing activities, consolidating manufacturing networks, and outsourcing production to less costly third-party manufacturers. These strategic initiatives require effective technology transfer—smoothly moving technical knowledge, processes, and analytical requirements between the different parties involved. Technology transfer also affects companies' ongoing operations—from research through commercial production. It underlies all key development and manufacturing activities needed to successfully bring a product to market (Figure 1).

Figure 1. Technology transfer from research through commercial production

Despite the strategic role that technology transfer plays in today's industry, it often does not get the attention it deserves. Many organizations manage transfers as isolated, nonstrategic events involving little more than a procedural exchange of process documents between sending and receiving parties. But without repeatable, scalable processes, companies are forced to reinvent the wheel each time technology changes hands. This leads to a variety of inefficiencies, such as suboptimal allocation of resources, extended cycle times, higher development costs, and quality and compliance issues.

Quick Recap

Companies should treat technology transfer as a key lever of their operational strategy and establish a comprehensive approach to ensure ongoing best practices. Generally, companies that have mastered technology transfer manage it proactively as a core competency of strategic importance. By integrating their processes and technologies from early development through commercial production, these firms are well ahead of the pack in cycle time, cost, and quality performance. Some best-in-class companies, for example, have reduced transfer cycle times by at least 20% to 30% through eliminating redundant activities. Cost reductions have ranged from 50% to 70% with improved alignment of processes and elimination of redundant activities. Quality improvements have resulted in fewer compliance problems identified during health authority inspections: fewer questions regarding chemistry and manufacturing control elements, fewer inspection days, and fewer FDA-483 observations. Moreover, validation runs for API, formulation, and analytical methods have been successful on their first attempt—eliminating the need for repeated runs to validate the processes.

Figure 2. An integrated approach to technology transfer

Some companies still regard technology transfer as a merely tactical procedure. To start changing this corporate mindset, it is necessary to build a clear consensus on the value of technology transfer: Can it help expand global reach? Can it increase knowledge and utilization of new technologies and process capabilities? Does it provide access to additional manufacturing capacity and low-cost manufacturing options outside an existing network? By explicitly articulating the broad value proposition, management can elevate the importance of technology transfer in the organization and establish a corporate-wide approach to technology transfer.

One approach for implementing a successful technology transfer is to integrate strategy, organization, and processes both within and across organizations (Figure 2). The key building blocks of this approach include: